A Pennsylvania patient safety organization says some wireless devices and apps that monitor newborns often cause parents unnecessary worry while doing little to protect a baby’s health.
The ECRI Institute, a research organization that evaluates medical devices, procedures and processes, and the Children’s Hospital of Philadelphia recently examined five models of infant physiological monitors introduced over the past two years, with names such as MonBaby, Baby Vida and Owlet, at costs ranging from $150 to $300, ECRI says.
The devices work with an electronic sensor attached to a baby’s sock that monitors vital signs and alerts parents on their smartphones if, for instance, an infant’s oxygen saturation level drops, says ECRI. But pediatric experts argue that such devices may cause undue alarm to parents, with no evidence of medical benefits, especially to healthy babies, ECRI says.
“These devices are marketed aggressively to parents of healthy babies, promising peace of mind about their child’s cardiorespiratory health,” says Dr. Christopher Bonafide , a pediatrician and safety expert with Children’s Hospital of Philadelphia. “But there is no evidence that these consumer infant physiological monitors are life-saving or even accurate, and these products may cause unnecessary fear, uncertainty, and self-doubt in parents.”
Wireless infant monitors are not subject to approval by the Food and Drug Administration and there is a lack of information on the safety of such devices, says ECRI.
“There is no publicly available evidence that these baby monitors are accurate in measuring a baby’s vital signs,” says ECRI executive director of Health Devices David Jamison. “And since these baby monitors are not regulated by the FDA, we have to question what testing has been done to assure the safety and quality of these designs.”
ECRI and Children’s Hospital say the FDA needs to take a stronger role in approving infant wireless apps and watching out for false advertising. More clinicians also need to conduct more research.
Owlet Baby Care, which raised $15 million during its latest investment round in November, says the company is being proactive in putting out devices that are safe and widely used. “We have done extensive product safety testing, such as biocompatibility studies and FCC testing, and the Owlet Smart Sock is in compliance with U.S. Consumer Product Safety Commission requirements,” the company says. “We have conducted third-party accuracy studies that were submitted to the FDA as part of our recent 510(k) application, which review is pending for a medical version of the product.”
“While many of the statements in the JAMA opinion paper about the present lack of evidence behind certain products has merit, Owlet is actively addressing and resolving these concerns,” says Owlet medical director Dr. Ken Ward.